Opacity technology

ABSTRACT

A catheter device comprising a chamber containing an opacity enhancing substance is disclosed. The opacity enhancing substance is in a dried or semi-dried form within the chamber of the device. Release of a liquid into the chamber suspends the substance and forms an opacity enhancing solution that is released into the lumen of the device in order to enhance the opacity of the device for imaging.

This application is a continuation application of U.S. patentapplication Ser. No. 13/173,414, filed Jun. 30, 2011, which claimspriority to U.S. Provisional Patent Application Nos. 61/344,355, filedon Jul. 6, 2010, and 61/344,543, filed on Aug. 17, 2010. The entirety ofall of the aforementioned applications is incorporated herein byreference.

FIELD

The present invention relates generally to medical devices and, inparticular, to devices for introducing an opacity enhancing materialinto a medical catheter or hollow lumen devices, such as balloons.

BACKGROUND

Balloons and catheters are used throughout the body in various lumenssuch as vascular, neurovascular and non-vascular lumens or cavities. Inorder to give the devices some radio visibility during use, the devicesmay have material embedded in the distal tip or various markerpositions.

In some cases, the devices are insufflated with various solutions tomake the devices visible under fluoroscopy. The problem with using asolution-filled device is that the device may become sticky or stiff, orhave increased deflation or inflation times, making the device difficultto work with or hindering the ability of the practitioner to control thedevice in vivo.

There is a need for catheter devices that have increased visibility invivo for imaging devices, but that are insertable in a deflated state,such that they are easier to control and to work with.

SUMMARY

One aspect of the present invention relates to a catheter devicecomprising a elongated catheter body having a proximal end and distalend and a conduit within the catheter body; and a mixing chamber at theproximal end of the catheter body, wherein the mixing chamber has afirst port for receiving a liquid and is in fluid communication with theconduit, wherein the mixing chamber is configured to allow an opacityenhancing substance in the mixing chamber to be suspended, dissolved ordiluted with a liquid received from the input port to form an opacityenhancing liquid. When connected to a permeable catheter or ballooncatheter, the mixing chamber can also be used to carry drugs that willbe released at a treatment site through the permeable catheter orballoon catheter.

In an embodiment, the mixing chamber further comprises an opacityenhancing substance.

In a related embodiment, the opacity enhancing substance is in a dried,semidried or concentrated liquid form.

In another embodiment, the opacity enhancing substance is adhered to theinner surface of the chamber.

In another embodiment, the mixing chamber further comprises a membraneor screen that separate the mixing chamber into two or more sections.

In another embodiment, the catheter device further comprises a balloonat the distal end, wherein the balloon is in fluid communication withthe mixing chamber through the conduit.

In another embodiment, the mixing chamber further comprises a secondport for receiving the opacity enhancing substance.

In another embodiment, the mixing chamber is configured to create aturbulent flow to mix the opacity enhancing substance with the liquid.

In another embodiment, the opacity enhancing substance is selected fromthe group consisting of iodine compounds, barium sulfate, bariumiridium, iron particles, tungsten, fluorescent dyes, gadolinium, andmicrobubbles.

In a related embodiment, the iodine compound is an ionic iodine compoundor a non-ionic iodine compound.

In a related embodiment, the ionic iodine compound is selected from thegroup consisting of diatrizoic acid, metrizoic acid, ioglicic acid, orsalts thereof.

In another related embodiment, the non-ionic iodine compound is selectedfrom the group consisting of iopadimol, iohexol, ioxilan, iopromide, andiodixanol.

In another embodiment, the catheter is selected from the groupconsisting of balloon catheters, vascular catheters, cardiac catheters,arterial catheters, venous catheters, neurovascular catheters,intestinal catheters, esophageal catheters, urinary catheters, and Foleycatheters.

In another related embodiment, the catheter device further comprises astent at the distal end of the catheter body.

In another embodiment, the mixing chamber is configured to receive aremovable and replaceable cartridge containing the opacity enhancingmaterial.

In a related embodiment, the removable and replaceable cartridge furthercontains a drug, to be used with a permeable catheter or ballooncatheter.

In another embodiment, the opacity enhancing material is contained in apouch, packet, capsule or bag that is inserted into the mixing chamberthrough an aperture.

In another embodiment, the opacity enhancing material is contained in atablet, pellet, pill, disc or wafer that is inserted into the mixingchamber through an aperture.

Another aspect of the present invention relates to a mixing devicecomprising a mixing chamber having a first port for connecting to aliquid delivery device, a second port for connecting to a catheter, andan opacity enhancing material inside the mixing chamber, wherein themixing chamber is configured to allow the opacity enhancing substance tobe suspended, dissolved or diluted with a liquid received from the inputport to form an opacity enhancing liquid.

In one embodiment, the opacity enhancing substance is in a dried,semi-dried or concentrated liquid form.

In another embodiment, the opacity substance is adhered to the innersurface of the chamber.

In another embodiment, the mixing chamber further comprises a membraneor screen that separate the mixing chamber into two or more sections.

In another embodiment, the opacity enhancing material is contained in aremovable and replaceable cartridge.

In another embodiment the mixing chamber further comprises a third portfor receiving the opacity enhancing substance.

In another embodiment, the mixing chamber is configured to create aturbulent flow to mix the opacity enhancing substance with the liquid.

Another aspect of the present invention is a method of imaging a ballooncatheter in a subject in need thereof, comprising the steps of:introducing into a lumen of the subject a balloon catheter devicecomprising a mixing chamber, wherein the mixing chamber is in fluidcommunication with the balloon catheter; admixing an opacity enhancingmaterial with a liquid in the mixing chamber to form an opacityenhancing liquid, advancing the opacity enhancing liquid into theballoon catheter to inflate a balloon; and obtaining an image of theballoon in said subject.

In one embodiment, the opacity enhancing liquid further contains atherapeutic agent and the balloon catheter comprises a balloon that ispermeable to the therapeutic agent.

The device and the method of the present invention may be used inprocedures such angioplasty, angiography, balloon septostomy balloonsinuplasty, catheter ablation, administration of intravenous fluids,medication or parenteral nutrition with a peripheral venous catheter,drainage of fluid collections, e.g. an abdominal abscess, temporaryblockage of a passage or lumen, expansion of a narrowed passage orlumen, expansion of a narrowing of the intestine, drainage of urine fromthe kidney by percutaneous nephrostomy, draining urine from the urinarybladder by urinary catheterization, and suprapubic catheterization.

Further objectives, features and advantages of the invention will beapparent from the following detailed description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purposes of this disclosure, unless otherwise indicated,identical reference numerals used in different figures refer to the samecomponent.

FIG. 1 shows a representative view of a catheter with a balloon attachedat a distal end.

FIG. 2 shows a representative view of a balloon attached to a catheter.

FIG. 3 is a perspective view of an embodiment of a mixing chamber.

FIG. 4 shows a perspective view of another embodiment of a mixingchamber that contains a hollow canister for holding the opacityenhancing substance.

FIG. 5 is a perspective view of another embodiment of a mixing chamber.

FIG. 6 is a perspective view of an embodiment of a mixing chamber with atwo piece design.

FIG. 7 is a perspective view of another embodiment of a mixing chamberwith a two piece design.

FIG. 8 is a perspective view of another embodiment of a mixing obundboc.

FIG. 9 is a perspective view of an embodiment of a mixing chamberdesigned to create a turbulent flow.

FIG. 10 is a perspective view of another embodiment of a mixing chamber.

FIG. 11 is a perspective view of another embodiment of a mixing chamber.

FIG. 12 is a perspective view of another embodiment of a mixing chamberdesigned to create a turbulent flow.

FIG. 13 is a perspective view of another embodiment of a mixing chamberdesigned to create a turbulent flow.

FIGS. 14A and 14B are perspective top view and side view, respectively,of another embodiment of a mixing chamber.

FIG. 15 shows an image of an esophageal balloon comprising a bariumsulfate solution admixed at a concentration of 0.04 μg barium sulfate in10 ml of sterile H₂O.

FIG. 16 shows an image of an esophageal balloon comprising a bariumsulfate solution admixed at a concentration of 20 mg barium sulfate in20 ml of sterile H₂O.

FIG. 17 shows an image of an esophageal balloon comprising a bariumsulfate solution admixed at a concentration of 0.16 g barium sulfate in20 ml of sterile H₂O.

FIG. 18 shows an image of a balloon illuminated with a solution ofbarium sulfate in sterile H₂O.

FIG. 19 shows an image of a balloon comprising a barium sulfate solutionadmixed at a concentration of 60 μg barium sulfate in 20 ml of sterileH₂O. The opacity enhancing material is added in an amount large enoughto allow an operator to see the balloon clearly but small enough toallow the operator to see the anatomy through the balloon.

FIG. 20 shows an image of a balloon comprising a barium sulfate solutionadmixed at a concentration of about 125 mg barium sulfate in 20 ml ofsterile H₂O.

FIG. 21 shows a perspective drawing of an embodiment of the mixingchamber in an expanded view (A) of the body of the device comprising themixing chamber, a cylinder for containing the opacity substance and acap; as well as an assembled view of the device (B).

FIG. 22 shows a horizontal longitudinal cut-away view (A) and atransverse cut-away view (B) through the mixing chamber of the device ofFIG. 21.

FIG. 23 shows alternate perspective views (A & B) of a mixing chamber ofthe present invention comprising a female Luer lock receptacle at oneend and a male Luer lock fitting at the other end, with a centralreceptacle for inserting a cylinder containing the opacity substanceinto the mixing chamber.

FIG. 24 shows an exploded view of a device of the present invention,having an interchangeable plug that fits into the side of the mixingchamber.

FIG. 25 shows a horizontal longitudinal cut-away view (A) and atransverse cut-away view (B) through the mixing chamber of the device ofFIG. 24.

FIG. 26 shows top and bottom (A and B) and side (C) alternateperspective views of a mixing chamber of the present inventioncomprising a female Luer receptacle at one end and a male Luer fittingat the other end with a central receptacle for introducing the opacitysubstance into the mixing chamber.

FIG. 27 shows additional perspective views of the mixing chamber of FIG.26. (A & B) show the bottom of the device and the outer surface of thecap that snaps into the opening of the central receptacle. (C) shows thetop of the device and the inner surface of the cap. (D) is a view of thetop of the device showing the central receptacle. (E) is a view of theinner surface of the cap. (F) shows the cap affixed into the centralreceptacle.

FIG. 28 shows alternate perspective views (A-E) of the mixing chamber ofFIG. 23 comprising a female Luer lock receptacle at one end and a maleLuer lock fitting at the other end, with a central receptacle forinserting a cylinder containing the opacity substance into the mixingchamber.

FIG. 29 shows alternate perspective views of the cap for the device ofFIG. 28. (A & C) show the top surface of the cap. (B) shows aperspective view of the cap from the side. (D) shows the interiorsurface of the cap. (E) is a perspective view of the mixing chamberdevice and the cap. (F) depicts the cap affixed to the mixing chamber.

FIGS. 30A-C show perspective views of a cylinder for containing theopacity substance that can be inserted into the central receptacle of amixing chamber device of the present invention.

FIGS. 31A-C depict exemplary mesh/screen material that is incorporatedinto cylinders and/or mixing chambers of the present invention forretaining the opacity substance and/or aiding in the admixture of theopacity substance with the liquid to form the opacity solution.

DETAILED DESCRIPTION

While this invention may be embodied in many different forms, there aredescribed in detail herein specific preferred embodiments of theinvention. This description is an exemplification of the principles ofthe invention and is not intended to limit the invention to theparticular embodiments illustrated.

The present invention provides a device that provides visibility/opacityof the device that allows the practitioner to see the device underimaging wherein the visibility/opacity substance could be free floatinginside the device in a dried or semi-dried state that becomes activewhen a pharmaceutically acceptable solution is introduced into thedevice and mixed with the substance. Various catheter devices or hollowlumen structures are disclosed, wherein an opacity enhancing substancecan be adhered to the inner lumen of the device or structure orpositioned into the inner lumen as part of the application during orafter the manufacturing process. In certain embodiments, the opacityenhancing substance is positioned loosely or fixed into a naturalindentation, crevasse, hole, or other modulus that will allow theopacity enhancing substance to be attached to the inner lumen of thedevice or to be loosely adhered or fixed with a quick biodegradabletechnology that will allow the material to be suspended, activated ordissolved in the lumen of the catheter or the balloon using apharmaceutically acceptable carrier to allow the lumen and or balloonend of the catheter to have increased visibility under imaging devices.When connected to a permeable catheter or balloon catheter, the mixingchamber can also be used to carry drugs that will be released at atreatment site through the permeable catheter or balloon catheter.

Examples of a “dried” state of the opacity substance include, but arenot limited to a powder, granular, solid, cake, tablet or crystallineform. Examples of a “semi-dried,” or semi-liquid, state of the opacitysubstance include, but are not limited to a gel, slurry, paste, or aviscous liquid.

The terms “opacity enhancing substance,” “opacity substance,” and“visibility substance” refer to a medical contrast medium, or contrastagent, that increases or enhances the visibility of a medical device,such as a catheter or balloon, within the body of a subject for amedical imaging device or procedure. Exemplary opacity enhancingsubstances include, but are not limited to: iodine compounds, bariumsulfate, barium iridium, iron particles, tungsten, fluorescent dyes,gadolinium, and microbubbles.

Iodine compounds can be ionic (high osmolar) or non-ionic (low osmolar)compounds. Exemplary ionic iodine compounds may comprise diatrizoicacid, metrizoic acid, ioglicic acid, or salts thereof. Exemplarynon-ionic iodine compounds may comprise iopadimol, iohexol, ioxilan,iopromide, and iodixanol.

Microbubbles are bubbles composed of nitrogen or perfluorocarbon gassmaller than one millimeter in diameter, but larger than one micrometerencapsulated with a solid shell. The shell is made from a polymer, lipidor a protein such as serum albumin.

A medical imaging device or procedure is inclusive of any device ormethod used to locate, monitor or visualize a medical device, such as acatheter or balloon, within the body of a subject. Examples include, butare not limited to, X-ray, ultrasound, fluoroscopy, and magneticresonance imaging.

A catheter is an elongated tube that can be inserted into a body cavity,lumen, duct, or vessel. The process of inserting a catheter iscatheterization. In some uses, a catheter comprises a thin, flexibletube, or soft catheter. In other uses, it comprises a larger, solidtube, or hard catheter. A catheter left inside the body, eithertemporarily or permanently, may be referred to as an indwellingcatheter. A permanently inserted catheter may be referred to as apermcath.

Catheter devices which are useful in the present invention include alltypes of balloon catheters. A balloon catheter is a type of soft,flexible catheter with an inflatable balloon at its tip which is usedduring a catheterization procedure to enlarge a narrow opening orpassage within the body or to hold the catheter in place in a lumenduring a procedure. The deflated balloon catheter is positioned, theninflated to perform the necessary procedure, and deflated again in orderto be removed. In some embodiments, the balloon catheter may comprise astent, which is located around the balloon, expands when the balloon isinflated, and remains in place when the balloon is deflated. Types ofcatheters useful in the present invention include, but are not limitedto, vascular catheters, including cardiac catheters, arterial catheters,and venous catheters; neurovascular catheters; intestinal catheters;esophageal catheters and urinary catheters, such as Foley catheters.

Exemplary in vivo uses of a catheter of the present invention include,but are not limited to, angioplasty, angiography, balloon septostomy,balloon sinuplasty, catheter ablation, administration of intravenousfluids, medication or parenteral nutrition with a peripheral venouscatheter, drainage of fluid collections, e.g. an abdominal abscess,temporary blockage of a passage or lumen, expansion of a narrowedpassage or lumen, such as the intestine, drainage of urine from thekidney by percutaneous nephrostomy, draining urine from the urinarybladder as in urinary catheterization, e.g., the Foley catheter or evenwhen the urethra is damaged as in suprapubic catheterization.

An exemplary catheter device with a balloon is depicted in FIG. 1. Thedevice comprises a hub 1, an elongated catheter body 2 having at leastone conduit therein, the balloon 3 and a distal tip 4. The length anddiameter of the catheter body, the shape of the balloon and the volumeof the balloon are dependent upon the application the balloon catheteris used for. An embodiment of the balloon and distal end of the catheteris provided in FIG. 2.

In the present invention, the hub can be modified to contain an opacityenhancing substance in a dry, semi-dry, gel or concentrated liquid form.The modified hub comprises a lumen or chamber for containing thesubstance. The liquid for inflating the balloon is introduced into thelumen or chamber, where it is mixed with the opacity enhancingsubstance. Suitable liquids for mixing with the opacity enhancingsubstance include any pharmacologically acceptable liquid, such assterile water, saline, buffered solutions or any liquid known in the artas being suitable for the inflation of a balloon catheter. Subsequent tosaid mixing, the liquid enters into the catheter and inflates theballoon. Due to the presence of the opacity solution, the catheter andballoon are more visible for imaging.

For the present invention the hub of a balloon catheter can be modifiedto comprise a mixing chamber or lumen wherein the opacity enhancingsubstance is mixed with the liquid. In some embodiments, the mixingchamber or lumen is distal to the hub and is positioned in or proximalto the catheter (i.e., between the hub and the catheter). In stillanother embodiment, the invention contemplates that the mixing chamberor lumen is a separate article of manufacture that is attachable to theproximal end of the hub (i.e., the hub is between the mixing chamber andthe catheter), wherein the liquid is introduced into the mixing chamberfor mixing with the opacity enhancing substance, subsequently flowingthrough the hub into the catheter and inflating the balloon.

Some embodiments of the present device comprise a mesh, screen ormembrane in the mixing chamber or as a component of a cylindercontaining the opacity substance. In said embodiments, the pores oropenings of the mesh, screen or membrane are sufficiently small toprevent the dried, semi-dried or gel opacity substance from passingthrough said pores or openings. However, said pores or openings allowthe passage of liquid through the mesh, screen or membrane to admix withthe opacity substance to form the opacity solution. Said pores oropenings further allow the passage of the admixed opacity solution. Insome embodiments, said pores or openings are of a uniform size. In otherembodiments, said pores or openings are of differing sizes. In stillother embodiments, said pores or openings may be larger on one side ofthe mixing chamber or cylinder and smaller on the other side of themixing chamber or cylinder. In some embodiments, the said pores oropenings of the mesh, screen or membrane create turbulence in the mixingchamber when the liquid is introduced to enhance the admixture with theopacity substance.

In some embodiments of the invention, the opacity substance is containedin a pouch, packet, capsule or bag that is a separate article ofmanufacture from the mixing chamber. Said pouch, packet, capsule or bagis inserted into the mixing chamber through an aperture. Said apertureis then closed with a cap being securely affixed into the mouth of theaperture by snap-fit, screw-fit or other adherent application. In arelated embodiment, the pouch, packet, capsule or bag is made of a meshor screen or membrane having pores or openings sufficiently small toprevent the dried, semi-dried or gel opacity substance from passingthrough said pores or openings. However, said pores or openings allowthe passage of liquid through the mesh, screen or membrane to admix withthe opacity substance to form the opacity solution. Said pores oropenings further allow the passage of the admixed opacity solution outof the pouch, packet or bag. In another related embodiment, the pouch,packet, capsule or bag is made of a substance that is soluble in theliquid for inflating the balloon.

In another embodiment, the opacity substance is provided as a tablet,pellet, pill, disc or wafer that is a separate article of manufacturefrom the mixing chamber. The tablet, pellet, pill, disc or wafer issoluble in the liquid for inflating the balloon. Said tablet, pellet,pill, disc or wafer is inserted into the mixing chamber through anaperture. Said aperture is then closed with a cap being securely affixedinto the mouth of the aperture by snap-fit, screw-fit or other adherentapplication.

The catheter device of the present invention may also be used for drugdelivery to a treatment site. In one embodiment, the mixing chamber isconnected to a catheter or balloon that is permeable to a therapeuticagent, and the therapeutic agent is added to the mixing chamber togetherwith the opacity enhancing substance. The therapeutic agent may be inthe form of a tablet, pellet, pill, disc or wafer. The therapeutic agentmay be an antibiotic, an antimicrobial agent, an antiviral agent, anantibacterial agent, a thrombotic agent or a coagulant agent.

Mixing Chambers

The following are exemplary chambers for containing the opacityenhancing substance and mixing the substance with the liquid. Theillustrations depicted and described are exemplifications of the conceptfor each of the types of chambers and are not intended to exactly showthe shape or design of the chamber, nor to limit the scope of thedisclosure to the exact shape or design shown in a drawing.

FIG. 3 shows an exemplary mixing chamber, which may be a modified hub,wherein a bulbous or rounded chamber 5 contains the opacity enhancingsubstance in a dried or semi-dried form. The liquid is introducedthrough the port 6, admixed with the opacity enhancing substance in thechamber 5, yielding an opacity solution that passes into and through thecatheter 2 to inflate the distal balloon, allowing the balloon to bevisualized during imaging.

FIG. 4 shows another embodiment of a mixing chamber, wherein the opacityenhancing substance is retained in a cylinder 7. The cylinder 7 may besealed within the chamber at the time of manufacture, or the cylinder 7may be closed with a cap 8 that is securely affixed into the mouth ofthe cylinder 7 by snap-fit, screw-fit or other adherent application.Alternatively, the cylinder 7 is introduced into the mixing chamber 9through an aperture and the aperture is then closed with cap 8 beingsecurely affixed into the mouth of the aperture by snap-fit, screw-fitor other adherent application. One or more portions of the walls of thecylinder 7 are a screen or liquid permeable membrane or are perforatedsuch that, when the liquid is introduced through the port 6, it entersthe lumen 9 of the chamber, passes through the walls of the cylinder 7and admixes with the opacity enhancing substance inside the cylinder 7.The opacity solution then passes into and through the catheter 2 toinflate the distal balloon, allowing the balloon to be visualized duringimaging. FIGS. 26A-C depict an example of this embodiment as an articleof manufacture, with FIGS. 27A-F also depicting an exemplary snap-fitembodiment of the cap for the device and its fitment into the mouth ofthe cylinder. In one embodiment, the cylinder 7 may further contain adrug, which can be delivered to a treatment site by a drug permeablecatheter or balloon.

FIG. 5 shows another design of the mixing chamber. This design allowsthe opacity enhancing substance to be introduced into the cylinder 7through a port 10. Again, the liquid is introduced through port 6,enters the lumen 9 of the chamber, passes through the walls of thecylinder 7, admixes with the opacity enhancing substance and the opacitysolution passes into and through the catheter 2 to inflate the distalballoon, allowing the balloon to be visualized during imaging.

FIGS. 6 and 7 show mixing chambers with a two-piece design, in which oneof the two pieces is sealed during manufacture after the opacityenhancing substance is added. FIG. 6 contemplates a bulbous design forthe chamber, while FIG. 7 contemplates a more conical shape, with theapex of the cone being oriented towards the catheter 2. These two piecechambers may further contain an additional port 10. The liquid isintroduced through port 6, enters the chamber 5, and admixes with theopacity enhancing substance and the opacity solution passes into andthrough the catheter 2 to inflate the distal balloon, allowing theballoon to be visualized during imaging.

FIG. 8 shows another design of the mixing chamber. This design allowsthe opacity enhancing substance to be introduced into the chamber 5through a port 10. The liquid is introduced through port 6, enters thechamber 5, and admixes with the opacity enhancing substance and theopacity solution passes into and through the catheter 2 to inflate thedistal balloon, allowing the balloon to be visualized during imaging.

In certain instances, or with some opacity enhancing substances, it maybe desirable to create additional turbulence within the chamber in orderto more fully suspend or dissolve the opacity enhancing substance. Anexample of this concept is shown in FIG. 9, where the turbulence isresultant from the liquid introduced through port 6 flowing serpentinechannel 20 in the chamber 5, where it admixes with the opacity enhancingsubstance adhered onto the surface of the channel 20. The opacitysolution then passes into and through the catheter 2 to inflate thedistal balloon, allowing the balloon to be visualized during imaging. Inanother embodiment, the turbulence can be caused by baffles incorporatedinto the chamber.

FIG. 10 shows a perspective view of another variation of a chamberdesigned to create a turbulent flow.

In FIG. 11, the liquid is introduced through port 6 into a central lumen11 a, which is enclosed by a membrane or screen. The opacity enhancingsubstance is introduced through port 10 into a separate lumen 11 b thatsurrounds lumen 11 a and is also enclosed by a membrane or screen. Theliquid flows from lumen 11 a into lumen 11 b, where it admixed with theopacity enhancing substance to form the opacity solution which flowsinto the lumen of the chamber 9 and passes into and through the catheter2 to inflate the distal balloon, allowing the balloon to be visualizedduring imaging. In this embodiment, the screens or membranes createadditional turbulence for the suspension or dissolution of the opacityenhancing substance.

FIG. 12 provides another view of a turbulence design similar to FIG. 9.In this embodiment, the opacity enhancing substance 21 is adhered ontothe surface of a section of the serpentine channel 20. The turbulentflow of the liquid through the channel 20 will suspend or dissolve theopacity enhancing substance 21, thereby forming the opacity enhancingsubstance.

FIG. 13 depicts another exemplary chamber design wherein the increasedturbulence is the result of flow through a membrane or screen. In thisexample, the opacity enhancing substance is introduced through port 10into the mixing chamber 14. The liquid is introduced through port 6 intolumen 12, which is separated from the mixing chamber 14 by membrane 13.The liquid flows through membrane 13 into mixing chamber 14, where itadmixed with the opacity enhancing substance to generate the opacitysolution, which and passes into and through the catheter 2 to inflatethe distal balloon, allowing the balloon to be visualized duringimaging. In this embodiment, the screens or membranes create additionalturbulence for the suspension or dissolution of the opacity enhancingsubstance.

FIGS. 14A-B show a side view (A) and a top view (B) of a mixing chambercomprising an insertable canister 16 that contains an opacity enhancingsubstance. The canister 16 is loaded with the opacity enhancingsubstance and sealed with a cap 17 and inserted into the chamber 15. Thewalls of the canister 16 are a screen or membrane or are perforated suchthat, when the liquid is introduced through the port 6, it enters thelumen 15 of the chamber, passes through the walls of the canister 16,admixes with the opacity enhancing substance and the opacity solutionpasses into and through the catheter 2 to inflate the distal balloon,allowing the balloon to be visualized during imaging.

FIG. 21 depicts a rendering of an exemplary mixing chamber 30 of theinvention. FIG. 21A is an exploded view of the components of the mixingchamber 30, which comprising a receptacle 31, a cylinder 32 forcontaining the opacity substance and a cap 33. The cylinder 32 comprisesmesh 34 that holds the dried opacity substance, but allows liquid topass into the cylinder 32, where it admixed with the opacity enhancingsubstance to generate the opacity solution, which and passes into andthrough the catheter to inflate the distal balloon, allowing thecatheter and balloon to be visualized during imaging. In thisembodiment, the mesh 34 creates additional turbulence for the suspensionor dissolution of the opacity enhancing substance. Perspective view (B)depicts an assembled view of the mixing chamber 30. Cutaway drawings inthe longitudinal horizontal (FIG. 22A) and transverse planes (FIG. 22B)through the mixing chamber 30 show exemplary dimensions of the device.An exemplary cylinder for containing the opacity substance, without themesh, is depicted in FIG. 30A-C, while an example of mesh that can beincorporated into said cylinder is depicted in FIG. 31A-C.

In some embodiments, the mixing chamber 30 is a separate article ofmanufacture from the catheter and can be attached to the hub of thecatheter by way of a slip fitting, a Luer fitting, or a Luer lockfitting, for example. In an exemplary embodiment, FIG. 23 showsalternate perspective views (A & B) of a mixing chamber 30 of thepresent invention comprising a female Luer lock receptacle (36) at oneend and a male Luer lock fitting (37) at the other end, with a centralreceptacle 35 for inserting a cylinder containing the opacity substanceinto the mixing chamber 30. FIGS. 28A-E provide additional depictions ofthis embodiment as an article of manufacture. FIGS. 29A-E depict anexemplary cap for the receptacle in the mixing chamber into which can beinserted a cylinder comprising the opacity substance. An exemplarycylinder for containing the opacity substance, without the mesh, isdepicted in FIG. 30A-C, while an example of mesh that can beincorporated into said cylinder is depicted in FIG. 31A-C.

In some embodiments, the mixing chamber 30 can have at least oneadditional interchangeable element or plug 39 that forms part of thewall of the mixing chamber. This interchangeable element could be used,for example, to change the shape of the mixing chamber to modulate theturbulence of the mixing action when the liquid carrier is admixed withthe opacity substance in the cylinder or mixing chamber. An exemplary,exploded view of such a device is depicted in FIG. 24. Cutaway drawingsin the longitudinal horizontal (FIG. 25A) and transverse planes (FIG.25B) through the mixing chamber show exemplary dimensions of the devicemeasured in inches.

Control of Opacity

The intensity of the image and the level of opacity of the opacitysolution in the catheter and balloon can be controlled by varying theamount of opacity enhancing substance used and the volume of liquid usedto suspend or dissolve the opacity enhancing substance. In a preferredembodiment, the opacity enhancing substance is used in an amount largeenough to allow an operator to visualize a medical device, such as aballoon catheter, inside the body using an imaging device, but smallenough to allow the operator to see the anatomy through the image of themedical device.

FIG. 15 shows an X-Ray image of an esophageal balloon comprising abarium sulfate solution admixed at a concentration of 0.04 μg bariumsulfate in 10 ml of sterile H₂O, wherein the opacity of the balloon isnot intense.

In FIG. 16, the X-Ray image of the esophageal balloon is more intense.In this example, the balloon comprises a barium sulfate solution admixedat a concentration of 20 mg barium sulfate in 20 ml of sterile H₂O.

FIG. 17 shows an even more opaque X-Ray image of the esophageal balloon,comprising a barium sulfate solution admixed at a concentration of 0.16g barium sulfate in 20 ml of sterile H₂O.

FIG. 18 shows an X-Ray image of a balloon illuminated with a very lowconcentration solution of barium sulfate in sterile H₂O. The balloon isvisible as an outline and features behind the balloon are clearlyvisible.

FIG. 19 shows an X-Ray image of the same balloon comprising anintermediate barium sulfate solution admixed at a concentration of 60 mgbarium sulfate in 20 ml of sterile H20. The image of the balloon is moreintense, but feature behind the balloon are still visible.

In FIG. 20, the X-Ray image of the balloon is fully opaque, as featuresbehind the balloon are no longer visible. In this example, the ballooncomprises a barium sulfate solution admixed at a concentration of about125 mg barium sulfate in 20 ml of sterile H₂O.

The above description is for the purpose of teaching the person ofordinary skill in the art how to practice the present invention, and itis not intended to detail all those obvious modifications and variationsof it which will become apparent to the skilled worker upon reading thedescription. It is intended however, that all such obvious modificationsand variations be included within the scope of the present invention,which is defined by the following claims. The claims are intended tocover the mentioned components and steps in any sequence which iseffective to meet the objectives there intended, unless the contextspecifically indicates the contrary.

1. A catheter device comprising an elongated catheter body having aproximal end and distal end and a conduit within the catheter body; anda mixing chamber at the proximal end of the catheter body; wherein themixing chamber has a first port for receiving a liquid and a second portin fluid communication with the conduit, wherein the mixing chamberfurther comprises an opacity enhancing substance prior to introductionof a liquid through the first port, or further comprises a third portadapted to receive the opacity enhancing substance prior to introductionof a liquid through the first port, and wherein the opacity enhancingsubstance is disposed in the mixing chamber or in a structure configuredfor placement in the mixing chamber via the third port so that theopacity enhancing substance in the mixing chamber can become suspended,dissolved or diluted with a liquid received from the first port to forman opacity enhancing liquid.
 2. The catheter device of claim 1, whereinthe mixing chamber further comprises an opacity enhancing substance. 3.The catheter device of claim 2, wherein the opacity enhancing substanceis in a dried, semidried or liquid form.
 4. The catheter device of claim2, wherein opacity enhancing substance is adhered to the inner surfaceof the chamber.
 5. The catheter device of claim 1, wherein the mixingchamber further comprises a membrane or screen that separate the mixingchamber into two or more sections.
 6. The catheter device of claim 1,wherein the catheter device further comprises a balloon at the distalend, wherein the balloon is in fluid communication with the mixingchamber through the conduit.
 7. (canceled)
 8. The catheter device ofclaim 1, wherein the mixing chamber is configured to create a turbulentflow to mix the opacity enhancing substance with the liquid.
 9. Thecatheter device of claim 1, wherein the opacity enhancing substance isselected from the group consisting of iodine compounds, barium sulfate,barium iridium, iron particles, tungsten, fluorescent dyes, gadolinium,and microbubbles.
 10. The catheter device of claim 9, wherein the iodinecompound is an ionic iodine compound or a nonionic iodine compound. 11.The catheter device of claim 10, wherein the ionic iodine compound isselected from the group consisting of diatrizoic acid, metrizoic acid,ioglicic acid, or salts thereof.
 12. The catheter device of claim 10,wherein the non-ionic iodine compound is selected from the groupconsisting of iopadimol, iohexol, ioxilan, iopromide, and iodixanol. 13.The catheter device of claim 1, wherein the catheter is selected fromthe group consisting of balloon catheters, vascular catheters, cardiaccatheters, arterial catheters, venous catheters, neurovascularcatheters, intestinal catheters, esophageal catheters, urinarycatheters, and Foley catheters.
 14. The catheter device of claim 1,wherein the catheter device further comprises a stent at the distal endof the catheter body. 15-27. (canceled)
 28. The catheter device of claim2, wherein the mixing chamber further comprises a membrane or screenthat separate the mixing chamber into two or more sections.
 29. Thecatheter device of claim 28, wherein the membrane or screen has pores oropenings that are sufficiently small to prevent dried, semi-dried or gelopacity substance from passing through the membrane or screen.
 30. Thecatheter device of claim 1, wherein the catheter device comprises athird port adapted to receive the opacity enhancing substance prior tointroduction of a liquid through the first port.
 31. The catheter deviceof claim 30, wherein the opacity enhancing material is contained in aremovable and replaceable cartridge.
 32. The catheter device of claim30, wherein the opacity enhancing material is contained in a packet. 33.The catheter device of claim 30, wherein the opacity enhancing materialis contained in a tablet.
 34. The catheter device of claim 1, whereinthe opacity enhancing material further comprises a therapeutic agent.